Devices and methods for molecular diagnostic testing

Inventors

Andreyev, Boris • Moravick, Keith E. • Ciopyk, Brian • Briones, Victor • Loney, Gregory • De La Zerda, Adam • Ching, Jesus • Chu, Steven • Swenson, David • Huang, Helen

Abstract

A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Core Innovation

The invention relates to a molecular diagnostic apparatus that includes an amplification module irreversibly coupled within a housing and a detection module defining a detection channel in fluid communication with the amplification module and a reagent module. The amplification module includes a flow member and a heater, where the flow member defines a reaction volume or flow path configured to receive an input sample and the heater conveys thermal energy into the reaction volume or flow path to amplify a nucleic acid within the input sample to produce an amplified output containing a target amplicon.

The detection module includes a detection surface within the detection channel that retains the target amplicon when the amplified output flows across the detection surface at a first time, and the reagent causes production of a signal associated with the target amplicon after the reagent flows across the detection surface at a second time. The apparatus further includes a fluid pump disposed within the housing, where the fluid pump includes a movable member or actuator configured to move in different directions and generate flows of the amplified output and the reagent within the detection channel.

A control module within the housing includes a processor configured to control movement of the movable member or regulate a power input to an electric motor or actuator to control a rate of input flow through the flow channel. The heater includes heating portions configured to produce first and second temperature zones within different portions of the flow path, and the input flow is thermally cycled to amplify a nucleic acid to produce an output flow containing a target amplicon.

Claims Coverage

The independent claims cover three main inventive features. These features are heater-based amplification in a flow member, a detection module with a detection surface that retains target amplicon for time-separated signal production, and a controllable fluid pump with a processor-regulated motor or actuator to generate the sample and reagent flows.

Across the independent claims, the apparatus is defined by heater-based nucleic-acid amplification in a flow member producing an output containing a target amplicon, a detection channel with a detection surface that retains the target amplicon so that a reagent can be flowed later to produce a signal, and a controllable fluid pump whose operation is controlled by a processor.

Stated Advantages

Documented Applications